Quantification of Posterior Capsule Opacification in Pediatric Cataract

NCT ID: NCT02968290

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2017-11-30

Brief Summary

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The purpose of this study is to quantify the opacity of posterior capsule in pediatric cataract comparing two intraocular lens materials.

Detailed Description

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The eye exam at the first appointment will consist of anamnesis, external motor, evaluating strabismus and nystagmus, visual acuity with and without correction, biomicroscopy, fundoscopy, binocular ultrasound biometry, pachymetry and specular microscopy. The surgery will be performed by a single surgeon under general anesthesia. All participants will receive primary intraocular lens implantation as the randomization process, or hydrophobic acrylic material or hydrophilic acrylic. The implanted intraocular lens differ primarily in the material. The lens of hydrophobic acrylic materials (AcrySof SA60AT, Alcon Lab) single, folding part, material acrylate / methacrylate with UV protection AcrySof filter, optical diameter of 6.0 mm, total length of 13.0 mm, haptic angle of 0 degree with 360 degree double square edge, spherical convex earlier. The lens hydrophilic acrylic material (Akreos ADAPT, Bausch and Lomb) single, folding piece with optical diameter 6.00 mm and length de10.7 mm aspheric convex in anterior and posterior with absorbent UV, haptic angle 0 degree angulation . It has 4 attachment points (haptics) with 360 degree square double edge.

Conditions

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Posterior Capsule Opacification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hydrofobic material-Alcon AcrySof SA60AT

Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrofobic material.

Group Type ACTIVE_COMPARATOR

Cataract Surgery

Intervention Type PROCEDURE

Implant of intraocular lens hydrophobic or Implant of intraocular lens hydrophilic (Device)

Alcon AcrySof SA60AT

Intervention Type DEVICE

Implant of intraocular lens hydrophobic

Hydrophilic material-Bausch Lomb AkreosA

Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrophilic material.

Group Type ACTIVE_COMPARATOR

Cataract Surgery

Intervention Type PROCEDURE

Implant of intraocular lens hydrophobic or Implant of intraocular lens hydrophilic (Device)

Bausch Lomb AkreosA

Intervention Type DEVICE

Implant of intraocular lens hydrophilic

Interventions

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Cataract Surgery

Implant of intraocular lens hydrophobic or Implant of intraocular lens hydrophilic (Device)

Intervention Type PROCEDURE

Alcon AcrySof SA60AT

Implant of intraocular lens hydrophobic

Intervention Type DEVICE

Bausch Lomb AkreosA

Implant of intraocular lens hydrophilic

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* indication for cataract surgery

Exclusion Criteria

* traumatic cataract
* neurological diseases that do not allow the exams
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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camila ribeiro koch pena

Professor of medical residency of ophthalmology and PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Humberto Castro Lima

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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Brazil

References

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Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.

Reference Type RESULT
PMID: 15640920 (View on PubMed)

Gasper C, Trivedi RH, Wilson ME. Complications of Pediatric Cataract Surgery. Dev Ophthalmol. 2016;57:69-84. doi: 10.1159/000442502. Epub 2016 Apr 1.

Reference Type RESULT
PMID: 27043393 (View on PubMed)

Panahi-Bazaz MR, Zamani M, Abazar B. Hydrophilic Acrylic versus PMMA Intraocular Lens Implantation in Pediatric Cataract Surgery. J Ophthalmic Vis Res. 2009 Oct;4(4):201-7.

Reference Type RESULT
PMID: 23198075 (View on PubMed)

Lin H, Yang Y, Chen J, Zhong X, Liu Z, Lin Z, Chen W, Luo L, Qu B, Zhang X, Zheng D, Zhan J, Wu H, Wang Z, Geng Y, Xiang W, Chen W, Liu Y; CCPMOH Study Group. Congenital cataract: prevalence and surgery age at Zhongshan Ophthalmic Center (ZOC). PLoS One. 2014 Jul 3;9(7):e101781. doi: 10.1371/journal.pone.0101781. eCollection 2014.

Reference Type RESULT
PMID: 24992190 (View on PubMed)

Werner L, Tetz M, Feldmann I, Bucker M. Evaluating and defining the sharpness of intraocular lenses: microedge structure of commercially available square-edged hydrophilic intraocular lenses. J Cataract Refract Surg. 2009 Mar;35(3):556-66. doi: 10.1016/j.jcrs.2008.11.042.

Reference Type RESULT
PMID: 19251151 (View on PubMed)

Kleinmann G, Zaugg B, Apple DJ, Bleik J. Pediatric cataract surgery with hydrophilic acrylic intraocular lens. J AAPOS. 2013 Aug;17(4):367-70. doi: 10.1016/j.jaapos.2013.04.007. Epub 2013 Aug 6.

Reference Type RESULT
PMID: 23928003 (View on PubMed)

Other Identifiers

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University od São Paulo

Identifier Type: -

Identifier Source: org_study_id

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